Job Title: Complaint Investigator / Reviewer
Analyze complaint data and apply appropriate coding to complaint records, linking complaints to product improvements, product defects, and safety evaluations
Perform independent technical assessment on product quality complaints and post-market product quality analysis
Evaluate complaint data and confirm regulatory reportability decisions and risk assessments performed
Experience:
5 years’ experience
Bachelor’s degree in biomedical sciences, or other technical degrees
Working knowledge of appropriate global medical device regulations, requirements, and standards such as ISO 13485 and ISO9001, and FDA QSR. Medical Device and or other regulated industry (Pharma, IVD,) preferred.
An organized, analytical thinker with exceptional attention to detail
Experience in Complaint Handling and/or Symptom Coding